So it is perhaps a sort of progress that the British Medical Journal and the international Committee on Publication Ethics were able to organize a meeting on the subject in London last week, gathering representatives from universities, funders, journals and lobby groups to discuss how the problem could be tackled in the United Kingdom (see Nature http://doi.org/hmx; 2012). The meeting broke little new ground, but its organizers do, at least, deserve credit for trying.

A big part of the problem is the lack of perceived risk associated with misconduct. Some fraudulent researchers might be sociopaths who don’t care about the rules, but many others simply believe that they can anticipate the outcome of a research project, and see no downside to fabricating the required results to save time, or tweaking results to achieve a stronger signal. Either way, stronger action and punishments are needed to discourage such misbehaviour. (Meanwhile, for colleagues considering blowing the whistle, the risks are glaringly huge — witness the plight of scientists, such as cardiologist Peter Wilmshurst, who have raised questions and have faced the full force of Britain’s ludicrous libel laws as a result.)

Could publications such as this one do more to deter cheats? Unfortunately, we are often in no position to flag up even proven cases of misconduct, and thereby highlight the risks that miscreants run with their careers. Yes, it is a journal’s primary job to clean up the literature, but when papers are retracted owing to misconduct, the libel laws (again) often prevent our editors from saying so. We know that this leaves the affected communities frustrated and in the dark. It leaves us frustrated, too.

So, with journals unable to push towards greater integrity and universities often unwilling to do so, should funding agencies be leading the charge? It is, after all, their money that is wasted if misconduct does occur.

Funding agencies in the United States do sometimes investigate misconduct. Research funded by the National Institutes of Health and some other government agencies falls under the remit of the Office for Research Integrity (ORI), which has the power to bar researchers from receiving future funding. However, as Nicholas Steneck, director of the research-ethics programme at the Michigan Institute for Clinical and Health Research in Ann Arbor, told the London meeting, this process probably misses most major misconduct. And the ORI can’t initiate investigations: institutions must conduct their own inquiries first.

In the United Kingdom, there seems to be little appetite for launching an overarching ORI-type regulator. Certainly, the existing independent advisory group, the UK Research Integrity Office in Falmer, is clear that it has no desire to take on such a role. British funding councils — in collaboration with the country’s universities — have chosen instead to produce a ‘concordat’ detailing good practice, to which institutions will be expected to sign up. This is laudable, but unlikely to strike fear into fraudsters and fabricators.

So, how can Britain highlight cases of misconduct and discourage it in future? Ultimately, the incentives probably need to come from on high, and the government could get the ball rolling by commissioning an anonymous survey on misconduct that UK researchers have witnessed and perpetrated. An official audit would offer a strong platform for others to build on — perhaps with a parliamentary inquiry and subsequent report on the damage done to UK science by misconduct, and an assessment of the options for tackling it and the investment needed. Funders and universities could then work together to establish common definitions of what counts as misconduct, and how it will be punished. And if a reform of the libel laws goes ahead, journals and other scientists would be able to do more to highlight and expose miscreants.

Sounds ambitious? If the solutions were easy, there wouldn’t be a problem to discuss. But there is, so we must face it.

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 [Apr. 1, 2011, NC]- BEI's Director Jennifer Miller speaks at North Carolina Central University School of Law's  5th annual symposium on Intersection of the Biotechnological and Legal Worlds. More info here.

[Mar. 23, 2011, Vancouver]- Student Biotechnology Network (SBN) hosts Genomics, Ethics and Industry Practice panel to explore social, legal and ethical implications of current and future scientific endeavors with BEI’s Executive Director Jennifer Miller. More info here.

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[Oct. 15-16, 2010, Princeton]

[May 6, 2010, Chicago] Biotechnology Industry Organization (BIO) selects BEI to direct ethics panel for the 2010 BIO International Convention.  The convention is the largest global event for the industry.  Presidents Bill Clinton and George W. Bush, will appear for a moderated discussion on domestic and foreign policy.   Al Gore will deliver a keynote on climate change and BEI will direct the panel: Ethics and Biopharmaceutical R&D: Who Should Be Responsible for Tomorrow’s Drugs? more info here.

• Chair and moderator:  Jennifer Miller, Exec. Director, Bioethics International
• Richard Hubbard, MD, Senior Director, External Medical Affairs, Pfizer
• Mark Feinberg, VP, Medical Affairs and Policy, Merck
• Robert Baughman, PhD,VP, MannKind Corporation
• Stephen Latham, JD, PhD, Deputy Director, Yale Interdisciplinary Center for Bioethics
• Ellen Strahlman, MD, MHSc, Senior VP, Chief Medical Officer, GlaxoSmithKline

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[2009 - Present] BEI’s Executive Director, Jennifer Miller, serves as regular commentator for Fox News Live, CBS2 News, and other local and international media on a diverse spectrum of ethical issues.

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[June 5, 2009] Science Magazine features Bioethics International and its Executive Director, Jennifer Miller, full article here.

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[January 29, 2009, NYC] BEI’s Executive Director, Jennifer Miller, serves as expert for Fordham University’s Conference, ADVANCING CLIMATE JUSTICE: TRANSFORMING THE ECONOMY, PUBLIC HEALTH, & OUR ENVIRONMENT. Panelists’ Bios Conference Agenda

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[June 17-19, 2009, Texas] Bioethics International partners with the World Health Care Congress for The World Health Care Congress Leadership Summit on Emergency Medicine Business Management and Planning - Disaster Preparation & Surge Planning Ÿ Reimbursement & Regulatory Requirements. Jennifer E. Miller, Executive Director, Bioethics International speaks about optimizing and regulating situational standards of care and how to overcome the ethical challenges associated with alternate care sites and situations. More information here.

[Science] Her colleagues still call her “the mistake.” In late 2001, Jennifer Miller was on track to become a theoretical physicist. “My dream was to work for NASA and go to Mars,” says Miller, who was then a senior at Fordham University. She was flying high–so high that when she received an e-mail invitation to speak at a 2-day stem-cell bioethics conference in Rome, she proudly agreed. She knew a little bit about stem cells, she says, and she figured that they wanted a young person’s perspective. “I call it innocence, naïveté, hubris–I don’t know.” As she arranged her travel, rescheduled her final exams, and boarded the plane, she never had an inkling of the truth: The invitation was an error.

Miller attended the closed-door conference anyhow, thanks to an acquaintance who sneaked her onto the translator roster. She heard scientists, philosophers, theologians, and policymakers discuss cutting-edge stem cell technologies and their ethical ramifications. “I loved it,” she says, but “I was unsettled.” Who would have access to these new, lifesaving technologies–only the rich? Would the new technologies make the world a better place or more unjust? “An invention itself is good usually,” she says, “but it’s how we use it and apply it and distribute it that can cause some inequalities.”

Today, Miller, 29, runs Bioethics International, a Manhattan-based nonprofit that helps the medical industry, including hospitals and pharmaceutical companies, grapple with everyday and exceptional ethical questions. Miller has organized a United Nations–affiliated conference and advised the American Medical Association. In the next year, she plans to launch an ethical-standards program for the pharmaceutical, biotechnology, and medical-device industries. With her innovations–undertaken with the same bold spirit, though less naïveté, as that first trip to Rome–she has earned her place on many podiums. “I don’t think that science or business is for a timid person,” she says.

Finding a niche

Miller returned from the 2001 conference intending to follow her original plan to go into physics. But then she received an e-mail invitation that was not an error: Based on her participation at the conference, the pontifical university Regina Apostolorum in Rome, which hosted the conference, offered her a scholarship to study in their new School of Bioethics for a year following her graduation from Fordham. She resisted at first, but a physics professor finally persuaded her to take the opportunity. Studying in Italian, a language she scrambled to learn in a summer course, Miller discovered that her physics training helped her work logically and methodically through ethical problems. In ethics, she says, “there are, just like in science, procedures for helping you reach a good conclusion. I never knew that.”

Miller returned to the United States in 2003. At the time, few people had heard of bioethics. Her parents hadn’t and worried that further study wouldn’t lead to a viable career. “I’m superpractical,” she says, so she decided to hedge: She’d work as a clerk in health care law at a firm in New York City, and she’d go to Rome four to five times a year to do intensive study toward a doctorate. That way, if things didn’t work out, she could always parlay her ethics training into a career in health care law.  Read more and full article here…

In her spare time, she started to develop a niche for herself in health care ethics. People called her for advice, referred by friends and family. She remembers advising a nurse whose blind patient refused hydration, a decision that would lead to the patient’s death. Could the nurse just give the hydration through an existing IV without the patient’s knowledge? No, Miller explained, because that would violate the patient’s freedom to choose, which is fundamental to human dignity. “Then she understood, and then she was very at peace,” Miller says. She says she probably could have run an ethics hotline for medical professionals, but “I thought the best thing I could do was empower them to make their own decisions.”

First, she needed to build a framework for making ethical decisions that she could teach others. She reviewed all the philosophical possibilities–including utilitarianism, which promotes the “greatest good for the greatest number,” principlism, and virtue theory, which are often taught in medical schools. She decided on the person-centered approach, created by Emmanuel Mounier in the early 20th century. Mounier’s approach puts individuals at the center of decision-making, she says, “rather than whatever else would be tempting–like money, winning a war, or ideology.” She finished building the framework at the end of 2006. In early 2007, she left the law firm and went to work full-time at her new nonprofit, Bioethics International.

The last thing to fall into place was Bioethics International’s specialty. In early 2007, while working with theNational Disaster Life Support Education Consortium of the American Medical Association, Miller met Anna Pou. Pou was a New Orleans doctor who was arrested but ultimately not indicted for second-degree murder after she gave lethally high doses of painkillers to critically ill patients in the days following Hurricane Katrina. Miller realized, and Pou agreed, that hospitals desperately needed ethics training for emergency situations.

At the time, flu pandemics were the emergency-preparedness “topic du jour,” she says. She developed a 1-hour pandemic training session for hospital staffs that used the person-centered approach to teach “the ‘why’ behind the ‘what’ ” of standard triage protocol, which is designed to maximize the number of survivors. In a small exploratory study, Miller found that health care workers were more likely to use the protocol after the training than before. Recently, thanks in part to the increased attention to pandemics because of the swine-flu outbreak, she has partnered with the Harvard Humanitarian Initiative to expand that study. She hopes that more evidence on the effectiveness of ethics training will lead to more funding. “On a national level, people are always saying the word ‘ethics,’ but they need to start funding it better,” she says.

A bridge between disciplines

In all her activities, Miller tries to act as a bridge linking the players in the bioethics world: science, law, philosophy, and religion. Each of those disciplines has tools that it can bring to bear on ethical questions, she says, to arrive at answers that everyone can agree on. “That’s one of my driving forces,” she says: “to try and build consensus and help people realize that these are human issues. These are not religious, ideological issues.”

“This sort of interdisciplinary dialogue is essential,” says Mark Mercurio, director of the Yale Pediatric Ethics Program. Last year, he spoke at a United Nations–affiliated conference that Miller co-organized about the ethical consequences of new medical technologies. It featured scientists, doctors, philosophers, and theologians–not unlike that first conference Miller attended in Rome. “There’s an energy that she brings to this which is welcome,” he says.

But not everyone is so open to her message of bridge building, Miller says. Her secret weapon is her youth: A petite woman with a small voice, at first she seems even younger than she is. It can disarm people long enough to get them to actually listen, she says. “I think [audiences] look at her initially as a young, inexperienced person,” says Ferdinando Mirarchi, emergency department medical director at Hamot Medical Center in Erie, Pennsylvania. But once she starts talking, he says, “they begin to pay attention quickly.”

Her latest project, the World Council for Ethical Standards, stems from the perception that the pharmaceutical industry puts profits before people–an accusation that’s sometimes warranted and sometimes not, she says. Miller intends for the project to rebuild trust between the industry and consumers by creating a set of ethical guidelines for the pharmaceutical industry and related industries such as biotechnology and medical devices. Representatives from medicine, research, religion, philosophy, patient advocacy, law, and industry will sit on the council, which will give a seal of approval to companies that comply with the standards they develop.

The seal will encourage companies to act ethically, Miller says, and then inform the public when they do. She hopes to have it running within a year. That should also mark the end of her studies, because she is developing the seal’s guidelines as her doctoral dissertation.

Miller is eager to tackle other ethical quandaries, including electronic medical records and artificial intelligence. She no longer has any doubt that her expertise will be in demand. She recently appeared as an expert on a local news station discussing the ethics of cloning and joined the advisory committee of a nonpartisan Washington, D.C., think tank, the Center for Policy on Emerging Technologies. These days, “everybody’s calling for ethics reform–even on Wall Street,” she says. “We’re there.”

-Chelsea Wald

Bioethics International partners with the World Health Care Congress for:  The World Health Care Congress Leadership Summit on Emergency Medicine Business Management and Planning – Disaster Preparation & Surge Planning Ÿ Reimbursement & Regulatory Requirements 

Hear from Jennifer E. Miller, Executive Director, Bioethics International and learn to Optimize and Regulate Situational Standards of Care.  Overcome ethical challenges associated with alternate care sites and situations.

Register today!   SAVE $300 on the current registration rate when you mention PROMO CODE: JPD282! (Discount not valid on Government rate.)  

January 29, 2009

BEI’s Executive Director, Jennifer Miller, served as an expert for Fordham University’s Conference, ADVANCING CLIMATE JUSTICE: TRANSFORMING THE ECONOMY, PUBLIC HEALTH, & OUR ENVIRONMENT, organized by WeAct. 

• Panel Topic:  Climate Justice Adaptation: Public Health and Emergency Preparedness
• Location: Fordham University Lincoln Center Campus, 113 W. 60th St., New York City
• Panelists’ Bios          Conference Agenda
• Panel Description: Emergency preparedness for climate disasters is an increasingly essential and immediate element of climate change adaptation. Panelists will examine how municipalities are preparing for imminent climate disasters and the need to protect communities from displacement, disinvestments and disempowerment in the immediate aftermath of climate disasters.

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May 23, 2008

BEI organized the UN-affiliated 2008 bioethics conference to address current and emerging global healthcare and ethics concerns. Panelists were selected from BEI’s global network of experts including from Yale University, University of Pennsylvania, Columbia University, Harlem Hospital, NY Presbyterian Hospital, et al. Panels included:

1. To Have the Best Child Possible: The Coming Age of “Procreative Beneficence?”
2. Ethics and Pharmaceutical R&D: Who Should Be Responsible for Tomorrow’s Drugs?
3. Saying “No” to Patients: Medical Professionals as Conscientious Objectors

The conference was held on May 23, 2008 at 777 United Nations Plaza in New York City. A cocktail reception at the Consulate General of Romania featuring an Argentinean tango followed the conference. Further information: UN Bioethics Panels & Panelists Photo Gallery 

WATCH UN CONFERENCE VIDEO HERE